BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2083652 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05718
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE, IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE WAS NOT RETURNED TO BAXTER AND A LOT NUMBER WAS NOT PROVIDED; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT OF A LEAK AND REPORTED SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE COMPLAINT INFORMATION, THE CAUSE OF THE ALARM WAS DETERMINED TO BE LEAK IN DISPOSABLE (UNSPECIFIED LOCATION). SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT REGARDING SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE(HC) DISPLAY DURING USE. THE PATIENT WAS ADVISED TO CONTACT THE HOSPITAL. THE PATIENT EXPLAINED THAT WHEN THE EQUIPMENT WAS DISCONNECTED, HE REALIZED THE TABLE WAS FULL OF LIQUID. THE PATIENT COULD NOT DETERMINE THE ORIGIN OF THIS LIQUID. DURING A FOLLOW-UP, THE PATIENT STATED THAT HE WAS PRESCRIBED ANTIBIOTICS UPON CONTACTING THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE